Salicylic acid 99.5-105.0% (by acidimetry on anhydrous substance), EMPROVE® ESSENTIAL Ph. Eur., BP, USP, SAFC®

Supplier: MERCK PRODUCTION CHEMICALS
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1.00631.1000 1.00631.9024
1.00631.1000EA 94.3 GBP
1.00631.1000 1.00631.9024
Salicylic acid 99.5-105.0% (by acidimetry on anhydrous substance), EMPROVE® ESSENTIAL Ph. Eur., BP, USP, SAFC®
Salicylic acid
Formula: (HO)C₆H₄CO₂H
Boiling Pt: 336 °C (1013 hPa)
Melting Pt: 157…159 °C
Density: 1.443 g/cm³ (20 °C)
Flash Pt: 157 °C
Storage Temperature: Ambient
MDL Number: MFCD00002439
CAS Number: 69-72-7
EINECS: 200-712-3
Merck Index: 13,08411
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Specification Test Results

Assay (acidimetric; calculated on dried substance) 99.5 - 100.5 %
Assay (HPLC, calc.on dried substance) 98.0 - 102.0 %
Identity passes test
Appearance of solution (10 %; ethanol 96 %) passes test
Chloride (Cl) ≤ 0.0100 %
Sulfate (SO₄) ≤ 0.0200 %
Related substances / HPLC (EP) (4-Hydroxybenzoic acid) ≤ 0.1 %
Related substances / HPLC (EP) (4-Hydroxyisophthalic acid) ≤ 0.05 %
Related substances / HPLC (EP) (Phenol) ≤ 0.02 %
Related substances / HPLC (EP) (Largest unspecified impurity) ≤ 0.05 %
Related substances / HPLC (EP) (Sum of all impurities) ≤ 0.2 %
Related substances / HPLC (USP) (4-Hydroxybenzoic acid) ≤ 0.1 %
Related substances / HPLC (USP) (4-Hydroxyisophthalic acid) ≤ 0.05 %
Related substances / HPLC (USP) (Phenol) ≤ 0.02 %
Related substances / HPLC (USP) (Largest unspecified impurity) ≤ 0.05 %
Related substances / HPLC (USP) (Sum of all impurities) ≤ 0.2 %
Residual solvents (ICH Q3C) excluded by manufacturing process
Sulfated ash ≤ 0.05 %
Loss on drying ≤ 0.5 %
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
corresponds to Ph Eur, BP, USP

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